ObjectiveTo assess the clinical utility of point‐of‐care (POC) capillary blood glucose (CBG) testing in the assessment of gestational diabetes mellitus (GDM) during oral glucose tolerance test (OGTT).DesignProspective cohort study.SettingAntenatal clinics at King's College Hospital.PopulationWomen screened for GDM between March and June 2020.MethodsThe CBG was measured using the POC StatStrip® test and the venous plasma glucose (VPG) was measured by Roche analyser (Cobas 8000 c702). GDM was diagnosed based on the 2015 National Institute for Health and Clinical Excellence (NICE) Clinical Guideline criteria. The two methods were compared statistically using Analyse‐It 5.40.2.Main outcome measuresDiagnostic sensitivity, specificity, positive and negative predictive values (PPV and NPV) for the POC StatStrip® test, compared with VPG measured by reference laboratory method.ResultsA total of 230 women were included. The number and percentage of women with glucose concentrations above the GDM threshold using the POC StatStrip® test versus laboratory VPG measurement was 15 (6.5%) versus eight (3.4%) at fasting and 105 (45.6%) versus 72 (31.1%) at 2 h, respectively. The sensitivity and specificity values (and 95% CIs) for the POC StatStrip® test were 88% (52%–99%) and 97% (93%–98%) at fasting and 97% (91%–99%) and 79% (71%–84%) at 2 h, respectively. However, the specificity and the NPV for the POC StatStrip® test for concentrations of ≤5.0 mmol/L at fasting or <7.5 mmol/L at 2 h were 100%, and the sensitivity and the PPV for concentrations of >9.5 mmol/L at 2 h were 100%.ConclusionsIn our cohort the POC measurement of CBG cannot entirely replace the laboratory method for the OGTT; however, it can be used to rule out/rule in GDM for glucose concentrations of ≤5.0 mmol/L at fasting or <7.5/>9.5 mmol/L at 2 h.

中文翻译：

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即时血糖检测在评估妊娠糖尿病中的临床效用：前瞻性队列研究

目的评估口服葡萄糖耐量试验（OGTT）期间即时（POC）毛细血管血糖（CBG）检测在评估妊娠糖尿病（GDM）中的临床效用。设计前瞻性队列研究。在国王学院医院设置产前诊所2020 年 3 月至 6 月期间对女性进行 GDM 筛查。方法使用 POC StatStrip® 测试测量 CBG，并使用罗氏分析仪 (Cobas 8000 c702) 测量静脉血浆葡萄糖 (VPG)。 GDM 的诊断依据是 2015 年美国国家健康与临床卓越研究所 (NICE) 临床指南标准。使用 Analyse-It 5.40.2 对两种方法进行统计比较。主要结果指标 POC StatStrip® 测试的诊断敏感性、特异性、阳性和阴性预测值（PPV 和 NPV）与参考实验室方法测量的 VPG 相比。结果总计其中包括 230 名女性。使用 POC StatStrip® 测试与实验室 VPG 测量相比，血糖浓度高于 GDM 阈值的女性人数和百分比在空腹时分别为 15 名 (6.5%) 和 8 名 (3.4%)，在空腹时分别为 105 名 (45.6%) 和 72 名 (31.1%)。分别为2小时。 POC StatStrip® 测试的敏感性和特异性值（以及 95% CI）在空腹时为 88% (52%–99%) 和 97% (93%–98%)，在空腹时为 97% (91%–99%)。 2 小时时分别为 79% (71%–84%)。然而，对于空腹时浓度≤5.0 mmol/L或2小时时浓度<7.5 mmol/L，POC StatStrip®测试的特异性和NPV为100%，对于浓度>9.5 mmol/L的敏感性和PPV 2小时时为100%。结论在我们的队列中，CBG的POC测量不能完全取代OGTT的实验室方法；然而，它可用于排除/排除 GDM 空腹时葡萄糖浓度≤5.0 mmol/L 或 2 小时<7.5/>9.5 mmol/L。